FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 3111981
·
Received May 14, 2013
Report
- Report Number
- 6000030-2013-00114
- Event Type
- Injury
- Date Received
- May 14, 2013
- Report Date
- April 25, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J10856R26, IMPLANTED: (B)(6) 2001. PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED "HARDCORE WITHDRAWAL" AFTER IMPLANT; IT WAS INITIALLY WRITTEN OFF AS A VERTIGO ATTACK BECAUSE THE PUMP HAD CAUSED THE PATIENT TO HAVE SOME REALLY BAD VERTIGO. THE PATIENT WAS SICK FOR 3 DAYS AND IT WAS HORRIBLE. THE PATIENT WAS VOMITING, WAS SWEATING, AND COULDN'T GET OUT OF BED. IT WAS LATER DETERMINED THAT THE CATHETER HAD BEEN SLICED AT IMPLANT AND THE CATHETER HAD BROKEN OFF; THERE WAS A PIECE FLOATING IN HER CEREBRAL SPINAL FLUID. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213280 | SYNCHROMED EL | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | RICE CREEK MFG | 8627-18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |